针对失眠的数字认知行为疗法与挪威多发性硬化症患者失眠的数字患者教育相比:随机对照试验的研究协议
Simen Berg Saksvik1, Liv Marie Rønhovde1, Kristine Ytrehus-Lynum1
1St.Olavs Hospital Department of Research and Development, Trondheim University Hospital, Trondheim, Norway.
Sleep advances : a journal of the Sleep Research Society
|November 24, 2025
概括
针对失眠的数字认知行为疗法 (dCBT-I) 可能会改善多发性硬化症 (MS) 患者的睡眠质量. 这项研究研究了dCBT-I.
科学领域:
- 神经学 神经学
- 睡眠医学 睡眠医学
- 数字健康数字健康
背景情况:
- 失眠常见于多发性硬化症 (MS),影响生活质量和大脑健康.
- 建议用于失眠的认知行为疗法 (CBT-I),但面临着访问限制.
- 数字CBT-I (dCBT-I) 提供了一个可扩展的解决方案,但其在MS中的有效性尚未被证明.
研究的目的:
- 评估dCBT-I与患者教育 (PE) 对MS患者失眠的有效性.
- 为了确定失眠严重程度的改善是否与疲劳,心理健康和认知功能的好处相关.
- 用健康登记册数据评估长期结果.
主要方法:
- 一个随机对照试验,涉及来自挪威多发性硬化病登记处的550名参与者.
- 参与者被随机分配1:1接受dCBT-I或PE.
- 结果在多个时间点进行评估,最长可达5年,包括动图和注册数据.
主要成果:
- 主要终点:9周内自我报告的失眠严重程度的差异.
- 二级终点:疲劳,心理健康,认知功能,睡眠,生活质量和资源利用.
- 探索失眠严重程度对其他结果的调解效应.
结论:
- 这项试验将提供关于dCBT-I在MS患者失眠的疗效的关键数据.
- 结果将告知数字治疗的潜力,以改善MS患者的多方面的结果.
- 这项研究旨在解决多发性硬化患者中无法获得的失眠治疗的未满足需求.
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